Shiley - Laryngectomy Tube - Covidien LP

Duns Number:058614483

Device Description: Laryngectomy Tube

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More Product Details

Catalog Number

-

Brand Name

Shiley

Version/Model Number

6LGT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K962173,K962173

Product Code Details

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Device Record Status

Public Device Record Key

b5e77d85-7fc5-494d-bd5c-78ac84774e5d

Public Version Date

July 14, 2022

Public Version Number

5

DI Record Publish Date

August 28, 2015

Additional Identifiers

Package DI Number

60884522007097

Quantity per Package

108

Contains DI Package

50884522007090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"COVIDIEN LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132
2 A medical device with a moderate to high risk that requires special controls. 8540
3 A medical device with high risk that requires premarket approval 202
U Unclassified 40